Ka la 27 Mmesa, 2024 - HumanwellCaps e hlophisitse Thupelo ea Tsebo ea Motheo ea cGMP bakeng sa basebetsi ba eona molemong oa ho khothaletsa{2}}ntlafatso ea boleng bo holimo ea HumanwellCaps, ho kenya tšebetsong leano la Sehlahisoa Pele, ho potlakisa sebopeho sa machabeng, ho fana ka{3}lihlahisoa le lits'ebeletso tsa boleng bo holimo bakeng sa bareki ba malapeng le ba kantle ho naha, ho netefatsa boleng le polokeho ea lihlahisoa tse ka bang teng, le ho fokotsa boleng ba tlhahiso le boleng ba sehlahisoa. Thupelo ena e nkiloe ke setsebi se nang le boiphihlelo mosebetsing oa tsamaiso ea boleng.
E le ho khothaletsa tsoelopele ea boleng bo holimo{{0}ea HumanwellCaps, ho kenya tšebetsong leano la Sehlahisoa Pele, ho potlakisa sebopeho sa machaba, ho fana ka-lihlahisoa le litšebeletso tsa boleng bo holimo bakeng sa bareki ba lehae le ba kantle ho naha, ho netefatsa boleng le polokeho ea tlhahiso ea lithethefatsi, ho fihlela sepheo sa ho ntlafatsa ts'ebetso e sebetsang le boleng ba sehlahisoa, ho fokotsa likotsi le liphoso tse ka bang teng. Hubei Renfu Pharmaceutical Excipients Co., Ltd. e ile ea tšoara thupelo ea "cGMP Training Basic Knowledge" bakeng sa basebetsi bohle ka la 27 Mmesa, 2024, e neng e rutoa ke litsebi tse phahameng tsa taolo ea boleng indastering.
Molula-setulo oa HumanwellCaps, Huang Jianhua, o hatelitse puong ea hae moketeng oa ho bula hore boleng ke bophelo ba khoebo. Ho khothaletsa mosebetsi oa ho kenya lifaele oa FDA DMF ke mokhoa o hlokahalang oa ho fihlela litlhoko tsa bareki ba malapeng le ba kantle ho naha bakeng sa boleng bo holimo, hape ke ntlha ea bohlokoa ea ho qala ho ntlafatsa butle-butle matla a bonolo a likhoebo. Kaho ea sistimi ea boleng e tsamaellanang le litlhoko tsa machabeng e sebetsa nakong eohle ea bophelo ba lihlahisoa, mme mosebeletsi e mong le e mong ke 'muelli oa k'hamphani. Hoa hlokahala ho tsoela pele ho ntlafatsa tsebo ea eona le boleng bo felletseng, ho lumela ka tieo mohopolong oa Koetliso ea Liphetoho, Boitšoaro bo Fetohang, le Phetoho ea Boitšoaro, ho latela ka tieo litlhoko tsa cGMP. Le Customer At First, ho ba moetapele oa lefats'e lefapheng la karolo ea karolo ea li-excipients tsa meriana ho theha boleng ba bareki.
Likahare tsa koetliso li akaretsa haholo-holo Chinese GMP (2010), US FDA cGMP 21CFR KAROLO EA 210 LE 211, EUGMP2008, ICH Q7 Review, tlhaloso e qaqileng le tšebeliso ea melaoana e meng, le boithuto ba linyeoe bo kopantsoeng le maemo a sebele a likhoebo. Ka nako e ts'oanang, e boetse e lebisa tlhokomelo ho lisebelisoa tse tloaelehileng le tsa khale tsa tlhahlobo le mekhoa ea tsamaiso ea boleng, e le hore barupeluoa ba ka ba le kutloisiso e tebileng ho tloha tsamaisong ea theory, empa hape le mosebetsing oa letsatsi le letsatsi.
Qetellong ea lenaneo la ho ruta, morupeli oa koetliso o ile a fana ka likarabo tse qaqileng lipotsong tsa barupeluoa. Ka nako e ts'oanang, k'hamphani e ile ea hlophisa le ho etsa Session ea ho Nahana le ho Abelana Mabapi le Qulity Management, baetapele ba mantlha ba HumanwellCaps le lihlooho tsa mafapha, baemeli ba basebetsi mabapi le koetliso ea maikutlo, basebetsi ba koetliselitsoeng ho arolelana le ho buisana, e le hore mehopolo le tlhokomeliso ea taolo ea boleng li kenelle mohopolong le boitšoarong ba mosebeletsi e mong le e mong.
